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 HIV and Coverage of the
th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2009)
 July 19 - 22, 2009, Cape Town, South Africa
 The material posted on HIV and about IAS 2009 is not approved by nor is it a part of IAS 2009.
Once-daily Lopinavir/ritonavir Works as Well as Twice-daily dosing in treatment-experienced Patients

Treatment-experienced patients who took lopinavir/ritonavir (Kaletra) once-daily as part of a combination antiretroviral regimen were as likely to achieve virological suppression and CD4 cell gains as those who took the drug twice-daily, but less frequent dosing was associated with better adherence, according to a presentation at the 5th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention last week in Cape Town, South Africa.

By Liz Highleyman

Prior research has shown that antiretroviral therapy (ART) containing once-daily lopinavir/ritonavir works as well as twice-daily dosing in treatment-naive HIV patients, and it has been approved for this indication since 2005. Sharlaa Badal-Faesen and an international team of colleagues aimed to determine whether this also holds true for treatment-experienced individuals.

Study M06-802 included 599 participants who were currently on ART but had a viral load above 1000 copies/mL. Though treatment-experienced, they had not previously used lopinavir/ritonavir; about half had used 1 other protease inhibitor (PI), however, and many had used 2 or more.

A majority of participants (66%) were men and the mean age was about 40 years; about half were white, one-third were black and one-third were Latino/Hispanic (the latter overlapped with the other groups). The median HIV viral load at baseline was about 4000 copies/mL and the median CD4 cell count was 254 cells/mm3. Resistance tests revealed a mean 1.2 major PI resistance mutations.

Participants were randomly assigned (1:1) to switch to either a once-daily dose of 800 mg lopinavir plus 200 mg ritonavir or else twice-daily doses of 400 mg lopinavir plus100 mg ritonavir. In addition, all received 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), selected according to treatment history and resistance profile. Patients received lopinavir/ritonavir in bottles with electronic caps to monitor adherence.


At week 48, using an intent-to-treat TLOVR (time to loss of virological response) analysis, 55.3% of patients taking once-daily lopinavir/ritonavir achieved HIV RNA below 50 copies/ml, compared with 51.8% of those taking twice-daily lopinavir/ritonavir.
This was not a significant difference, indicating that once-daily dosing was non-inferior to twice-daily administration.
Response rates were similar with once-daily and twice-daily dosing in patients with 0 to 2 major lopinavir resistance mutations.
However the response rate was 2-fold higher with twice-daily dosing among individuals with 3 or more such mutations (30.8% vs 57.1%).
CD4 cell increases were 135 cells/mm3 in the once-daily group and 122 cells/mm3 in the twice-daily group, again not a significant difference.
5% of patients in the once-daily arm and 7% in the twice-daily group withdrew due to adverse events.
About 25% of patients in both the once-daily and twice-daily groups experienced side effects, most commonly diarrhea (14% vs 11%) and nausea (3% vs 7%).
Similar proportions of patients in both arms had elevated cholesterol (about 7%) and triglyceride (about 5%) levels.
Emergence of new PI resistance mutations was uncommon in both groups among participants with inadequate virological suppression.
Once-daily administration was associated with significantly better adherence than twice-daily dosing.

"Through 48 weeks, lopinavir/ritonavir dosed [once-daily] or [twice-daily] had similar efficacy in treated-experienced subjects," the investigators concluded.

"Through 24 weeks, [once-daily] dosing of lopinavir/ritonavir resulted in higher treatment compliance than [twice-daily dosing]," they added. Both regimens were "[g]enerally well tolerated with few study drug-related discontinuations."

Projeto Praça Onze, UFRJ, Rio de Janeiro, Brazil; University of Witwatersrand, Clinical HIV Research Unit, Houghton, Johannesburg, South Africa; Hospital Civil de Guadalajara, Guadalajara, Mexico; Therapeutic Concepts, Houston, TX; Muñiz Hospital, HIV Outpatient Care Unit, Buenos Aires City, Argentina; Abbott Laboratories, Abbott Park, IL.


R Zajdenverg, S. Badal-Faesen, J Andrade-Villanueva, and others. Lopinavir/ritonavir tablets administered once- or twice-daily with NRTIs in antiretroviral-experienced HIV-1 infected subjects: results of a 48-week randomized trial (Study M06-802). 5th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention (IAS 2009). July 19-22, 2009. Cape Town, South Africa. Abstract TuAb104.















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